![2 IN 1 SUNSCREEN AND GRADUAL SELF-TANNER (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) AEROSOL, SPRAY [SUNLESS, INC]](https://medic.hrt.org//dailymed/images/7537d11c-09a1-aab5-e053-2991aa0af30e/MT_ProtectTan.jpg)
| NDC | 72553-001-01 |
| Set ID | 7537d11c-09a1-aab5-e053-2991aa0af30e |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Sunless, Inc |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
-
DOSAGE & ADMINISTRATION
Directions
• apply liberally 15 minutes before sun exposure
and at least every 2 hours. • children under 6 months of age:
ask a doctor. • Sun Protection Measures Spending time in
the sun increases your risk of skin cancer and early skin aging.
To decrease this risk, regularly use a sunscreen with a Broad
Spectrum SPF value of 15 or higher and other sun protection
measures including:
• limit your time in the sun, especially from 10 a.m. – 2 p.m..
• wear long-sleeved shirts, pants, hats, and sunglasses
• reapply: (bullet) after 80 minutes of swimming or sweating
• immediately after towel drying
• at lease every 2 hours
For an all-over perfect tan, hold 6-8 inches from skin and spray
with a quick, continuous side-to-side motion. Apply liberally 15
minutes before sun exposure. Hold 6-8 inches from skin and
spray with a quick, continuous side-to-side motion. When
applying to face, spray onto hands and rub onto skin. Reapply
after 80 minutes of swimming or sweating. Immediately after
towel drying. At least every 2 hours. - INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
2 IN 1 SUNSCREEN AND GRADUAL SELF-TANNER
avobenzone, homosalate, octisalate, octocrylene aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72553-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 15 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 8 g in 100 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) DIHYDROXYACETONE (UNII: O10DDW6JOO) PPG-3 BENZYL ETHER ETHYLHEXANOATE (UNII: 3N703GY99W) L-ERYTHRULOSE (UNII: WKK1W5B83O) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72553-001-01 170 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 09/07/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 09/07/2018 Labeler - Sunless, Inc (002603202) Establishment Name Address ID/FEI Business Operations Sunless, Inc 002603202 label(72553-001) Establishment Name Address ID/FEI Business Operations Chemolee Lab Corporation 809982754 manufacture(72553-001)
